Viibryd
- Generic Name: vilazodone hydrochloride
- Brand Name: Viibryd
- Drug Class: How Do SSRI/5HT-1A Partial Agonist Antidepressants Work?
Viibryd (Vilazodone Hydrochloride) side effects drug center
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- diarrhea,
- nausea,
- vomiting, and
- sleep problems (insomnia).
- easy bruising,
- unusual bleeding (nose, mouth, vagina, or rectum),
- blood in your urine or stools,
- purple or red pinpoint spots under your skin,
- agitation,
- hallucinations,
- fever,
- loss of coordination,
- fainting,
- overactive reflexes,
- very stiff (rigid) muscles,
- sweating,
- confusion,
- fast or uneven heartbeats,
- tremors,
- lightheadedness,
- racing thoughts,
- risk-taking behavior,
- decreased inhibitions,
- feelings of extreme happiness or sadness,
- extreme thirst with headache,
- weakness,
- trouble concentrating,
- memory problems,
- confusion,
- seizures (convulsions), or
- shallow breathing.
- a seizure (convulsions);
- blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- easy bruising, unusual bleeding;
- racing thoughts, unusual risk-taking behavior, decreased inhibitions, feelings of extreme happiness or sadness; or
- low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady.
- nausea, vomiting;
- diarrhea; or
- sleep problems (insomnia).
- Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see WARNINGS AND PRECAUTIONS].
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS].
- Increased Risk of Bleeding [see WARNINGS AND PRECAUTIONS].
- Activation of Mania or Hypomania [see WARNINGS AND PRECAUTIONS].
- Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS].
- Seizures [see WARNINGS AND PRECAUTIONS]
- Angle-Closure Glaucoma [see WARNINGS AND PRECAUTIONS].
- Hyponatremia [see WARNINGS AND PRECAUTIONS].
- Four placebo-controlled 8 to 10-week studies in 2,233 patients, including 1,266 VIIBRYD-treated patients; and
- An open-label 52-week study of 599 VIIBRYD-treated patients.
What Is Viibryd?
Viibryd (vilazodone hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) type antidepressant used to treat major depressive disorder in adults.
What Are Side Effects of Viibryd?
Common side effects of Viibryd include:
Contact your doctor if you have serious side effects of Viibryd including:
Dosage for Viibryd
The recommended dose for Viibryd is 40 mg once daily. Patients taking Viibryd will start with an initial dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then an increase to 40 mg once daily.
Viibryd During Pregnancy and Breastfeeding
Newborns exposed to Viibryd late in the third trimester of their mothers' pregnancies have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Doctors treating pregnant women with Viibryd shall consider whether the potential benefits outweigh the potential risks of treatment. Breastfeeding in women treated with Viibryd should be considered only if the potential benefit outweighs the potential risk.
Additional Information
Our Viibryd Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Viibryd (Vilazodone Hydrochloride)
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions and varying lengths of time, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.
The most commonly observed adverse reactions in VIIBRYD-treated patients with major depressive disorder (MDD) in placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were diarrhea, nausea, vomiting, and insomnia.
Patient Exposure
The safety of VIIBRYD was evaluated in 3,007 patients (18-70 years of age) diagnosed with MDD who participated in clinical studies, representing 676 patient-years of exposure. In an open-label 52 week study at 40 mg daily, 599 patients were exposed to VIIBRYD for a total of 348 patient-years.
The adverse reaction information presented below was derived from studies of VIIBRYD 20 mg and 40 mg daily in patients with MDD including:
These studies included a titration period of 10 mg daily for 7 days, followed by 20 mg daily for 7 days or to 40 mg daily over 2 weeks. In these clinical trials, VIIBRYD was administered with food.
Adverse Reactions Reported As Reasons For Discontinuation Of Treatment
In these studies, 7.3% of the VIIBRYD-treated patients discontinued treatment due to an adverse reaction, compared with 3.5% of placebo-treated patients. The most common adverse reaction leading to discontinuation in at least 1% of the VIIBRYD-treated patients in the placebo-controlled studies was nausea (1.4%).
Common Adverse Reactions In Placebo-Controlled MDD Studies
Table 2 shows the incidence of common adverse reactions occurring in ≥ 2% of VIIBRYD-treated patients and greater than the rate of placebo-treated patients in MDD Studies. There were no dose-related adverse reactions between 20 mg and 40 mg reported.
Table 2: Common Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and Greater than the Rate of Placebo-Treated Patients
| System Organ Class Preferred Term | VIIBRYD 40 mg/day N=978 | VIIBRYD 20 mg/day N=288 | VIIBRYD 40 mg/day N=978 |
| Gastrointestinal disorders | |||
| Diarrhea | 10% | 26% | 29% |
| Nausea | 7% | 22% | 24% |
| Dry mouth | 5% | 8% | 7% |
| Vomiting | 2% | 4% | 5% |
| Abdominal pain1 | 3% | 7% | 4% |
| Dyspepsia | 2% | 2% | 3% |
| Flatulence | 1% | 3% | 3% |
| Gastroenteritis | 1% | 1% | 2% |
| Abdominal distension | 1% | 2% | 1% |
| Nervous system disorders | |||
| Headache2 | 14% | 15% | 14% |
| Dizziness | 5% | 6% | 8% |
| Somnolence | 2% | 4% | 5% |
| Paresthesia | 1% | 1% | 2% |
| Psychiatric disorders | |||
| Insomnia | 2% | 7% | 6% |
| Abnormal dreams | 2% | 2% | 3% |
| Restlessness3 | 1% | 2% | 3% |
| General disorders | |||
| Fatigue | 3% | 4% | 3% |
| Cardiac disorders | |||
| Palpitations | <1% | 1% | 2% |
| Metabolism and nutrition disorders | |||
| Increased appetite | 1% | 1% | 3% |
| Musculoskeletal and connective tissue disorders | |||
| Arthralgia | 1% | 2% | 1% |
| Investigations | |||
| Increased weight | 1% | 1% | 2% |
| 1 Includes abdominal discomfort, abdominal pain upper, and abdominal pain. 2 Includes headache and tension headache 3 Includes restlessness, akathisia, and restless legs syndrome | |||
Sexual Adverse Reactions
Table 3 displays the most common sexual adverse reactions in the placebo-controlled MDD studies.
Table 3: Common Sexual Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and Greater than the Rate of Placebo-Treated Patients
| Preferred Term | Males | Females | ||||
| Placebo N=416 | VIIBRYD 20 mg/day N=122 | VIIBRYD 40 mg/day N=417 | Placebo N=551 | VIIBRYD 20 mg/day N=166 | VIIBRYD 40 mg/day N=561 | |
| Abnormal Orgasm* | <1% | 2% | 2% | 0% | 1% | 1% |
| Erectile dysfunction | 1% | 0% | 3% | - | - | - |
| Libido decreased | <1% | 3% | 4% | <1% | 2% | 2% |
| Ejaculation disorder | 0% | 1% | 2% | - | - | - |
| − Not applicable * Includes abnormal orgasm and anorgasmia | ||||||
Other Adverse Reactions Observed In Clinical Studies
The following list does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.
Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients:
Cardiac disorders: infrequent: ventricular extrasystoles
Eye disorders: infrequent: dry eye, vision blurred, rare: cataracts
Nervous System: frequent: sedation, tremor; infrequent: migraine
Psychiatric disorders: infrequent: panic attack
Skin and subcutaneous tissue disorders: infrequent: hyperhidrosis, night sweats
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of VIIBRYD. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure. Reports of adverse reactions temporally associated with VIIBRYD that have been received since market introduction and that are not listed above include the following:
General Disorders and Administration Site Conditions: irritability
Nervous System Disorders: sleep paralysis
Psychiatric Disorders: hallucinations, suicide attempt, suicidal ideation
Skin and subcutaneous tissue disorders: rash, generalized rash, urticaria, drug eruption
Gastrointestinal System: acute pancreatitis
Read the entire FDA prescribing information for Viibryd (Vilazodone Hydrochloride)
© Viibryd Patient Information is supplied by Cerner Multum, Inc. and Viibryd Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
